Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
ICH M13A: Changes to Step 2 ICH M13A: Changes to Step 2 AUCres ‘Percentage covered’ ICH M13A: Changes to Step 2 fixed or mixed effects model fixed or mixed effects model fixed or mixed effects model fixed or mixed effects model fixed or mixed effects model ICH M13A: Changes to Step 2 period within group and formulation period within group and formulation ICH M13A: Step 4 → 5 Formal ICH Procedure ICH M13A: Changes to Step 2	Helmut	2024-07-31 13:16	15	2024-09-10 08:12	2,915
EMA: ICH M13A coming into effect 25 January 2025	Helmut	2024-09-04 11:30	0		432
Handling and Retention of BA and BE Testing Samples Handling and Retention of BA and BE Testing Samples	dshah	2024-03-26 17:15	1	2024-04-23 16:16	2,443
EMA: Draft GL for OIPs EMA: Draft GL for OIPs EMA: Draft GL for OIPs	Helmut	2024-04-19 15:40	2	2024-04-22 14:07	2,234
Draft FDA guidance on data integrity in BA and BE studies	Ohlbe	2024-04-02 14:49	0		1,114
Handling and Retention of BA and BE Testing Samples	suchit_bhavsar	2024-03-27 04:09	0		1,250
Paper by the IPRP BEWGG	Ohlbe	2024-03-22 16:25	0		1,191
New EMA product specific guidance (PSG) New EMA product specific guidance (PSG)	SMA	2024-01-16 09:51	1	2024-01-17 10:12	1,906
ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) : FDA web site Knowledge is power… ICH M13A (IR BE): EMA consultation ICH M13A (IR BE): EMA comments received	Helmut	2022-12-23 09:05	9	2023-09-18 10:54	5,672
WHO Draft on BCS-based Biowaivers	Helmut	2023-08-29 11:18	0		1,535
EMA: New product-specific guidances How would you implement it? Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Range Range Range Range So many questions, so few answers Preliminary simulations Preliminary simulations Preliminary simulations Revisions of the PSGLs final Revisions of the PSGLs final EMA: No problems with many sampling time points… New simulations & some desultory thoughts SCNR. A heretic alternative. Simulated distributions	Helmut	2022-04-08 15:17	19	2023-06-30 11:50	7,904
ICH E6(R3) draft Guideline reaches Step 2 of the ICH process Validation of sample size estimations?	SMA	2023-05-24 08:37	1	2023-05-29 08:34	2,105
FDA draft guidance on transdermal systems	Ohlbe	2023-04-13 08:37	0		1,518
New guidance on Statistical Approaches to Establishing Bioequivalence A first look A first look A first look SAS strikes back SAS strikes back Outliers? Outliers? SAS strikes back model-based BE? model-based BE? Hooker, Moellenhoff et al. are moving MBBE forward model-based BE? A first look A first look Groups, sites… SxF SxF New guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Multi-group studies ad nauseam Multi-group studies ad nauseam Webinar: Recording available Speed kills	Relaxation	2022-12-02 15:53	24	2023-04-01 10:38	8,529
EMA Methodology Working Party EMA Methodology Working Party	Helmut	2022-10-01 09:53	1	2022-11-08 10:09	3,101